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Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLAST...

FDA Device Recall #Z-0908-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-0908-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 512,786 total units

Product Description

Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913; 7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914; 8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951; 9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952; 10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953; 11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954; 12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955; 13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956; 14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957; 15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958; 16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959; 17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A; 18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C; 19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F; 20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G; 21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1; 22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2; 23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB; 24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC; 25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD; 26) DIEP PACK,Catalog Number SBA11DPS10; 27) DIEP PACK,Catalog Number SBA11DPS11; 28) DIEP PACK,Catalog Number SBA11DPS12; 29) DIEP PACK,Catalog Number SBA11DPS13; 30) DIEP PACK,Catalog Number SBA11DPS14; 31) DIEP PACK,Catalog Number SBA11DPS15; 32) DIEP PACK,Catalog Number SBA11DPS16; 33) DIEP PACK,Catalog Number SBA11DPS17; 34) DIEP PACK,Catalog Number SBA11DPS18; 35) DIEP PACK,Catalog Number SBA11DPS19; 36) DIEP PACK,Catalog Number SBA11DPS20; 37) DIEP PACK,Catalog Number SBA11DPS21; 38) DIEP PACK,Catalog Number SBA11DPS22; 39) DIEP PACK,Catalog Number SBA11DPSB4; 40) DIEP PACK,Catalog Number SBA11DPSB5; 41) DIEP PACK,Catalog Number SBA11DPSB6; 42) DIEP PACK,Catalog Number SBA11DPSB7; 43) DIEP PACK,Catalog Number SBA11DPSB8; 44) DIEP PACK,Catalog Number SBA11DPSB9; 45) DIEP PACK,Catalog Number SBA11DPSBD; 46) DIEP PACK,Catalog Number SBA11DPSBE; 47) DIEP PACK,Catalog Number SBA11DPSBF; 48) DIEP PACK,Catalog Number SBA11DPSBG; 49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1; 50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2; 51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3; 52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4; 53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5; 54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6; 55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB; 56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC; 57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD; 58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE; 59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10; 60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11; 61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12; 62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13; 63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo

Reason for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot / Code Information

Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number 6788561 ; Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number 7332903 ; Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number 7163082 ; Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number 7332912 ; Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number 7332914 ; Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number J84K02 ; Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number J6278U ; Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number 5664102 ; Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number 5664101 ; Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number 5891310 ; Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number 5891313 ; Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number 6563987 ; Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number 6563989 ; Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number 6701853 ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671K ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671M ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671P ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number J86T83 ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number 5405627 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6487902 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6169297 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264570 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264565 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 6928765 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 7163033 ; Catalog Number PWOCRHGV1, UDI/DI 10197106262788 (EA)50197106262786 (CS), Lot Number 6701852 ; Catalog Number PWOCRHGV2, UDI/DI 10197106349755 (EA)50197106349753 (CS), Lot Number 6487903 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J53W72 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J5679F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J6050F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J84K04 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8124A ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8671N ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8123Y ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332915 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 22174441 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6702009 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6596397 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928759 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6806115 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928764 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928773 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163104 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280111 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7287567 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280109 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163082 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332904 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5140347 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5664101 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891309 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891308 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891310 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891312 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number J6367H ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891313 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6022128 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6025791 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6345522 ; Catalog Number SBA11CMCPD, UDI/DI 10888439548174 (EA)50888439548172 (CS), Lot Number J3464F ; Catalog Number SBA11DPS10, UDI/DI 10195594317010 (EA)50195594317018 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS11, UDI/DI 10195594401580 (EA)50195594401588 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS12, UDI/DI 10195594541651 (EA)50195594541659 (CS), Lot Number 5888374 ; Catalog Number SBA11DPS13, UDI/DI 10195594615192 (EA)50195594615190 (CS), Lot Number 5891311 ; Catalog Number SBA11DPS14, UDI/DI 10195594676995 (EA)50195594676993 (CS), Lot Number 5891305 ; Catalog Number SBA11DPS15, UDI/DI 10195594795788 (EA)50195594795786 (CS), Lot Number 6025787 ; Catalog Number SBA11DPS16, UDI/DI 10195594885267 (EA)50195594885265 (CS), Lot Number 5631069 ; Catalog Number SBA11DPS17, UDI/DI 10197106193761 (EA)50197106193769 (CS), Lot Number 6560944 ; Catalog Number SBA11DPS18, UDI/DI 10197106320099 (EA)50197106320097 (CS), Lot Number 6701853 ; Catalog Number SBA11DPS19, UDI/DI 10197106369456 (EA)50197106369454 (CS), Lot Number 6806113 ; Catalog Number SBA11DPS20, UDI/DI 10197106507544 (EA)50197106507542 (CS), Lot Number 6928764 ; Catalog Number SBA11DPS21, UDI/DI 10197106584798 (EA)50197106584796 (CS), Lot Number 7163104 ; Catalog Number SBA11DPS22, UDI/DI 10197106769782 (EA)50197106769780 (CS), Lot Number 7280108 ; Catalog Number SBA11DPSB4, UDI/DI 10888439689150 (EA)50888439689158 (CS), Lot Number J53W67 ; Catalog Number SBA11DPSB5, UDI/DI 10888439763836 (EA)50888439763834 (CS), Lot Number J53W73 ; Catalog Number SBA11DPSB6, UDI/DI 10888439995633 (EA)50888439995631 (CS), Lot Number J8671M ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number J9602T ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number 1933731664 ; Catalog Number SBA11DPSB8, UDI/DI 10195594075415 (EA)50195594075413 (CS), Lot Number 5135984 ; Catalog Number SBA11DPSB9, UDI/DI 10195594211462 (EA)50195594211460 (CS), Lot Number 5136018 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J34J43 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J46A99 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J70X20 ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8393U ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8123Y ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8671K ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8692Z ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6806114 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6928758 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631072 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891307 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891310 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631071 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 55693537 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264570 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264566 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264567 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6345523 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7280111 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7287567 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7332916 ; Catalog Number SBA11MXCP1, UDI/DI 10195594114985 (EA)50195594114983 (CS), Lot Number 5140342 ; Catalog Number SBA11MXCP2, UDI/DI 10195594347819 (EA)50195594347817 (CS), Lot Number 5478804 ; Catalog Number SBA11MXCP3, UDI/DI 10195594366544 (EA)50195594366542 (CS), Lot Number J6367F ; Catalog Number SBA11MXCP4, UDI/DI 10195594416027 (EA)50195594416025 (CS), Lot Number 5533336 ; Catalog Number SBA11MXCP5, UDI/DI 10195594756369 (EA)50195594756367 (CS), Lot Number 6022131 ; Catalog Number SBA11MXCP6, UDI/DI 10195594796587 (EA)50195594796585 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6563989 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number J86T81 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6264570 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6345522 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487904 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6487901 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6596397 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6788562 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332917 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163033 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163103 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7280107 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332910 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332906 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332907 ; Catalog Number SBA11PRH10, UDI/DI 10195594702298 (EA)50195594702296 (CS), Lot Number 5891314 ; Catalog Number SBA11PRH11, UDI/DI 10195594765477 (EA)50195594765475 (CS), Lot Number 6025786 ; Catalog Number SBA11PRH12, UDI/DI 10197106016053 (EA)50197106016051 (CS), Lot Number 6025791 ; Catalog Number SBA11PRH13, UDI/DI 10197106100172 (EA)50197106100170 (CS), Lot Number 6345522 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 157467 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 22L3440 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 6596396 ; Catalog Number SBA11PRHK3, UDI/DI 10888439745429 (EA)50888439745427 (CS), Lot Number J3464F ; Catalog Number SBA11PRHK4, UDI/DI 10888439947441 (EA)50888439947449 (CS), Lot Number J8124A ; Catalog Number SBA11PRHK5, UDI/DI 10888439992335 (EA)50888439992333 (CS), Lot Number J8692Y ; Catalog Number SBA11PRHK6, UDI/DI 10195594967062 (EA)50195594967060 (CS), Lot Number J86T83 ; Catalog Number SBA11PRHK7, UDI/DI 10195594464950 (EA)50195594464958 (CS), Lot Number 5631074 ; Catalog Number SBA11PRHK8, UDI/DI 10195594542108 (EA)50195594542106 (CS), Lot Number 5888374 ; Catalog Number SBA11PRHK9, UDI/DI 10195594659974 (EA)50195594659972 (CS), Lot Number 5891312 ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J4952D ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J5679G ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J7704H ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number J8123W ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number J84K01 ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number 5747232 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6806115 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928766 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928766 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928769 ; Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number 7332917 ; 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Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number J8693A ; Catalog Number SEN11ENN10, UDI/DI 10195594695897 (EA)50195594695895 (CS), Lot Number 6022064 ; Catalog Number SEN11ENN11, UDI/DI 10195594745288 (EA)50195594745286 (CS), Lot Number J6366P ; Catalog Number SEN11ENN12, UDI/DI 10195594780548 (EA)50195594780546 (CS), Lot Number 6279855 ; Catalog Number SEN11ENN13, UDI/DI 10195594845643 (EA)50195594845641 (CS), Lot Number 6345507 ; Catalog Number SEN11ENN14, UDI/DI 10197106019252 (EA)50197106019250 (CS), Lot Number 6487884 ; Catalog Number SEN11ENN15, UDI/DI 10197106239278 (EA)50197106239276 (CS), Lot Number 6775018 ; Catalog Number SEN11ENN16, UDI/DI 10197106321850 (EA)50197106321858 (CS), Lot Number 6701994 ; Catalog Number SEN11ENNY4, UDI/DI 10888439725339 (EA)50888439725337 (CS), Lot Number J53W33 ; Catalog Number SEN11ENNY5, UDI/DI 10195594086879 (EA)50195594086877 (CS), Lot Number 5138318 ; Catalog Number SEN11ENNY6, UDI/DI 10195594132033 (EA)50195594132031 (CS), Lot Number 5138317 ; Catalog Number SEN11ENNY7, UDI/DI 10195594216238 (EA)50195594216236 (CS), Lot Number J8670U ; Catalog Number SEN11ENNY8, UDI/DI 10195594322373 (EA)50195594322371 (CS), Lot Number J6366M ; Catalog Number SEN11ENNY9, UDI/DI 10195594375355 (EA)50195594375353 (CS), Lot Number 5138322 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J30T23 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J46A87 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J2649N ; Catalog Number SEN11ENNYQ, UDI/DI

Other Recalls from Cardinal Health 200, LLC

Recall # Classification Product Date
Z-1203-2026 Class II Chest Drainage Units and Accessories: Produc... Dec 26, 2025
Z-0897-2026 Class II ChemoPlus gowns: Product Code Product Descript... Nov 12, 2025
Z-0207-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0208-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0211-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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